The present invention generally relates to packaging for sutures and, more specifically, to disposable packages used during medical procedures to allow ready deployment of the suture as needed by the surgeon or other medical personnel.
Surgeons and other medical personnel use sutures on a daily basis. These sutures should be packaged in a manner allowing ready deployment, as necessary, as the need for suturing during surgery or other medical procedure arises. Various types of suture packaging have been proposed in the past and several types currently exist in commercial form. FIGS. 1 and 2 illustrate a suture 10 of the prior art comprised of a suture material 12 and suture needles 14, 16 at affixed opposite ends thereof. Generally, the most commercially successful types of suture packaging have involved uniformly looping the suture material in a figure eight configuration over itself within the package. Suture material 12 is generally formed from natural or synthetic materials that tend to become set into a kinked condition after being folded or looped and compressed for a period of time within the packaging. This characteristic, coupled with the current figure eight packaging techniques, cause the suture material to acquire a certain amount of stored energy much like a compressed spring. As the suture is taken from the package, it tends to come out all at once and, with the stored energy released in this uncontrolled manner, the suture material often becomes intertangled.
Suture 10 is schematically shown in FIG. 1 with the uniform loops 12a expanded for illustration purposes. Typically, these uniform loops 12a are compressed together and sandwiched between paper flaps within a flat, disposable package. Uniform loops 12a tend to become intertangled when removed from current packaging as discussed above, and as shown in FIG. 2, and further tend to create so-called xe2x80x9cair knotsxe2x80x9d. Air knots are created when one of the suture needles 14, 16 passes through one or more loops 12a or when loops become intertangled either while they are pulled from the package or after they are pulled from the package. When pulled taught, a knot is formed making the suture 10 unuseable. Also, various folds in the suture packaging can cause sutures 10, and especially fine or small diameter sutures, to hang up or become caught on fractured paper fibers caused by perforated edges. After the suture material 12 is removed from a conventional package, suture 10 does not hang straight as is most desirable, but tends to have significant bends or kinks created where the suture material 12 was looping back and forth within the packaging. Sometimes the suture is stretched or tensioned to remove the kinks before use, but this can result in breaking the suture. In emergency situations or other typical medical procedures, there is no time to allow the suture to relax and straighten. Therefore, the surgeon must use the less than desirable kinked suture.
To overcome various problems in this art, such as those mentioned above, as well as other problems in the art, it would be desirable to provide an improved suture package configured to reduce setting and subsequent kinking of the suture material, while also reducing the instances of loops becoming tangled or forming air knots when the suture is removed from the packaging.
The present invention therefore provides a suture package with several different features aimed at reducing various problems in this art. As one main feature, the invention provides a package which forms uneven loops, or loops of different length, to prevent the suture loops from becoming tangled and potentially forming air knots when removed from the package. To prevent kinking and to allow withdrawal of the suture in a controlled manner without tangling, the suture material is packaged in an accordion-style packaging material or other package configuration that physically separates adjacent loops of suture material. In the preferred accordion-style package, the suture material transitions over the folds between adjacent subpanels of an accordion-style panel at a gradual obtuse angle, such as an angle approaching a parallel orientation relative to the fold line. Inner folds of the accordion-style packaging are embossed to prevent pinching of the suture material, while outer fold lines are embossed or scored on the backside of the packaging to prevent the suture from hanging up on fractured paper fibers of the accordion-style panel. As used herein, the term xe2x80x9cembossingxe2x80x9d means applying discreet pressure along a fold line with or without scoring. An internal panel or member, preferably formed into a three-dimensional configuration or, in other words, at least having a three-dimensional thickness, prevents the package from being crushed and thereby pinching the suture material after packaging.
The loops formed along alternating subpanels of the accordion-style panel are initially formed on pins extending through the package from a packaging fixture as explained further below, but are retained by flaps after withdrawal of the pins at the end of the packaging operation. Loops formed on the opposite set of alternating subpanels are received by tabs at the bottom of the package. The tabs create a track for the suture material and slightly wedge the suture material in place. The tabs help prevent kinking and allow the suture material to be pulled from the package in a controlled manner by grasping and pulling the exposed suture needles from respective needle retention elements. Due to the accordion-style of the packaging, the suture material preferably does not fold or lay directly on top of itself. Rather, each loop of the suture material is separated by subpanels of the packaging. This further prevents the loops of suture material from hanging up on each other as they are pulled from the package. Although less desirable, it is also possible to place more than one loop between adjacent subpanels. Further, the transition between the suture material and the suture needle is straight and, therefore, no set or kink is created at this critical transition point.
The package of this invention may be a single suture package or a multi-suture package. For example, respective sutures may be retained on front and back sides of the accordion-style panel. The invention is also applicable to all types of suture material, but is especially advantageous with respect to those materials that easily take on a set. These materials tend to be monofilament sutures and sutures formed from natural gut. The invention is also especially suitable for packaging very fine suture materials, such as those used during cardiac surgery, hand surgery or other procedures using suture sizes of, for example, 6-0, 7-0 or higher. The foldable flaps in the suture packaging of this invention and the tabs create a certain amount of drag on the suture when the packaging is in its fully closed condition. This drag helps the suture to pull out in a controlled manner by causing the suture to retain its looped shape under each successive flap and tab as the suture material is being pulled out of the package.
In one general embodiment, the suture package has two long sides and two shorter ends. The suture needles are positioned for grasping preferably by exposing them at one of the ends and are removed with the suture material by pulling the suture from that end. Thus, the pulling occurs in a direction generally parallel to the length of the subpanels and the fold lines, if any, therebetween. In another embodiment, the suture needles are positioned for grasping preferably by exposing them along the length of one of the long sides of the suture package. Therefore, in this embodiment, the suture is pulled from the package in a direction generally transverse to the length of the subpanels and any fold lines therebetween. In this second embodiment, at least one advantage is provided by the fact that the suture material will not ride along the lengthwise edges of the subpanels during its removal. This can help prevent snagging and potential damage to the suture material caused by roughness along the lengthwise edges of the subpanels.
Generally, the method of packaging a suture in accordance with the invention includes looping a suture back-and-forth on a series of subpanels and superimposing the subpanels on each other such that adjacent loops of the suture are retained between adjacent, superimposed subpanels. Respective ends of the suture, which typically include needles attached thereto, are positioned for grasping in an accessible location. The superimposed subpanels are secured together in the form of a package either before or after the respective ends are positioned in the accessible location.
More specifically, the accordion-style panel is stretched out into a flat condition with the flaps containing the assembly pin holes flipped away from the accordion-style panel. The assembly pin holes of alternating subpanels on the accordion-type panel receive the assembly pins from the fixture. One of the suture needles is retained in a suitable needle retaining element at one end of the package and the suture material is looped back and forth over the assembly pins and then around the oppositely disposed tabs on each of the adjacent subpanels until reaching the final suture retaining element at the opposite end of the package. The assembly pins and the oppositely disposed tabs preferably force the suture material into curves of substantially constant radii to prevent sharp transitions in directions which may result in kinks. When this part of the packaging operation is complete, the flaps which were previously folded out of the way are folded back down over the pins. The pins are then withdrawn from the holes in the package by a suitable reciprocating feature of the packaging fixture and the accordion-style panel is folded together. The stiff internal panel is folded over first followed by the outside panel which is secured around the outside of the folded, accordion-style panel and retained in place. As one additional, alternative feature, the flaps which receive the pins may also be releasably connected to the underlying subpanels, for example, by forming perforations through the flap and underlying subpanel. This can be used to retain the suture loop in place beneath the flap until a user pulls the suture material and thereby breaks the connection between the flap and the underlying subpanel. At least one panel may have slots for receiving the assembly pins in an adjustable manner. This allows for adjustment in the length of, for example, the final loop of suture material to accommodate inconsistent lengths of different sutures during the packaging operation and allow the needle to reach and be retained in an accessible position with a straight transition between the needle and the suture material.
These and other objects, advantages, and features of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the preferred embodiments, taken in conjunction with the accompanying drawings.